The document discusses various types of impurities that can be present in pharmaceutical preparations and their sources. It describes six main types of impurities: 1) those that cause toxic or adverse reactions, 2) those that deteriorate the activity of the substance, 3) those that cause incompatibility, 4) those that cause technical problems, 5) those arising from humidity/temperature, and 6) those arising from coloring/flavoring substances. Potential sources of impurities discussed include raw materials, starting materials/reagents, solvents, equipment, intermediates generated during synthesis, and manufacturing defects. Proper control of sources like raw materials, processes, storage conditions, and packaging can help minimize impurities in pharmaceutical preparations.
Impurities in pharmaceuticals are the unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during formulation, or upon aging of both API and formulated APIs to medicines.
Limit tests, Introduction, Definition,
Limit Test For Chlorides
Limit Test For Sulphates
Limit Test For Iron
Limit Test For Lead
Limit Test For Arsenic
Impurities in pharmaceuticals are the unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during formulation, or upon aging of both API and formulated APIs to medicines.
Limit tests, Introduction, Definition,
Limit Test For Chlorides
Limit Test For Sulphates
Limit Test For Iron
Limit Test For Lead
Limit Test For Arsenic
Definition of Impurity
Types of Impurities
Sources of Impurity
foreign unwanted matter present in a compound which are differ from the actual molecular formula.
According to ICH “An impurity in a drug of the new drug substance that is not the substance”.
Chemically a compound is impure if it contains undesirable foreign matter i.e. impurities. Thus chemical purity is freedom from foreign matter
Impurities can have unwanted pharmacological or toxicological effect that seriously impact product quality and patient safety.
The International Conference on Harmonization (ICH) has formulated a workable guideline regarding the control of impurities.
Impurities in pharmaceutical are the unwanted chemicals that remains with the active pharmaceutical ingredient (API’s), or develop during formulation or upon aging of both API and formulated API’s to medicine.
The presence of the unwanted chemicals, even in small amount , may influence the efficacy and safety of pharmaceutical product
Sources and Types of Impurities by Professor BeubenzProfessor Beubenz
Useful for B Pharmacy Students
Subscribe to the YouTube Channel #Professor_Beubenz
https://www.youtube.com/channel/UC84jGf2iRN5VjwnQqi6qmXg?view_as=subscriber
Today's Topic Errors - Introduction, Sources of Errors, Types of Errors, Minimization of Errors, Accuracy, Precision, Significant Figures in Pharmaceutical Analysis subject in B.pharmacy 1st year as per JNTUA Syllabus...
Potentiometry, Electrochemical cell, construction and working of indicator an...Vandana Devesh Sharma
Potentiometry - Electrochemical cell -Construction and working of reference (Standard hydrogen, silver chloride electrode and calomel electrode)
Indicator electrodes (metal electrodes and glass electrode)
Methods to determine end point of potentiometric titration
and applications
Potentiometry is the method to find the concentration of solute in
A given solution by measuring the potential between two Electrodes
(reference and Indicator electrode) . Potentiometric titration involves
the measurement of the potential of the indicator electrode and
reference electrode.
In potentiometric titration reference and indicator electrodes are
immersed in the solution of particular analyte (titrand) and
potential of indicator electrode is measured with relation to
reference electrode.
Titrant is added in analyte (Titrand) and change in potential is noted
down.
At the end point there is sharp change in potential on indicator
electrode.
Graph is plotted between the indicator electrode potential and
volume of titrant added.
This method is used for determination of sharp end point.
Types of Potentiometric Titration
1. Acid-base titration 2. Redox Titration 3.Complexometric titration 4. Precipitation Titration
Introduction to Pharmaceutical ChemistryPriti Kokate
Chapter No. 1 from pharmaceutical chemistry , updated syllabus notes as per MSBTE
1.Introduction to pharmaceutical chemistry
Topic covers following bits
#Scope
#Objective
#Sources & Types Of Errors
#Impurities in Pharmaceuticals
#Limit Test For
*Chloride
*Sulphate
*Iron
*Heavy Metal
*Arsenic
Impurities in pharmaceutical substancesShaliniBarad
Impurities definition
Sources of impurities
Effect/ type of impurities
Limit test definition
Limit test Importance,
Principle & procedure of Limit test for iron, chloride, sulphate, arsenic & heavy metals.
Pharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptx
Isotopes Types of decay
Alpha rays, which could barely penetrate a piece of paper
Beta rays, which could penetrate 3 mm of aluminium
Gamma rays, which could penetrate several centimetres of lead
Units of Radioactivity:
Measurement of Radioactivity
The measurement of nuclear radiation and detection is an important aspect in the identification of type of radiations (, , ) and to assay the radionuclide emitting the radiation, suitable detectors are required. The radiations are identified on the basis of their properties.
e.g. Ionization effect is measured in Ionization Chamber, Proportional Counter and Geiger Muller Counter.
The scintillation effect of radiation is measured using scintillation detector and the photographic effect is measured by Autoradiography.
Gas Filled Detectors:
Ionization Chamber:
Proportional Counters:
Geiger-Muller Counter
Properties of α, β, γ radiations
Half –life of Radioelement
Sodium Iodide (I131)
Handling and Storage of Radioactive Material:
Storage of Radioactive Substances –
Precautions For Handling Radioactive Substances
Labelling of Radioactive Substances
Pharmaceutical Application Of Radioactive Substances
Definition of Impurity
Types of Impurities
Sources of Impurity
foreign unwanted matter present in a compound which are differ from the actual molecular formula.
According to ICH “An impurity in a drug of the new drug substance that is not the substance”.
Chemically a compound is impure if it contains undesirable foreign matter i.e. impurities. Thus chemical purity is freedom from foreign matter
Impurities can have unwanted pharmacological or toxicological effect that seriously impact product quality and patient safety.
The International Conference on Harmonization (ICH) has formulated a workable guideline regarding the control of impurities.
Impurities in pharmaceutical are the unwanted chemicals that remains with the active pharmaceutical ingredient (API’s), or develop during formulation or upon aging of both API and formulated API’s to medicine.
The presence of the unwanted chemicals, even in small amount , may influence the efficacy and safety of pharmaceutical product
Sources and Types of Impurities by Professor BeubenzProfessor Beubenz
Useful for B Pharmacy Students
Subscribe to the YouTube Channel #Professor_Beubenz
https://www.youtube.com/channel/UC84jGf2iRN5VjwnQqi6qmXg?view_as=subscriber
Today's Topic Errors - Introduction, Sources of Errors, Types of Errors, Minimization of Errors, Accuracy, Precision, Significant Figures in Pharmaceutical Analysis subject in B.pharmacy 1st year as per JNTUA Syllabus...
Potentiometry, Electrochemical cell, construction and working of indicator an...Vandana Devesh Sharma
Potentiometry - Electrochemical cell -Construction and working of reference (Standard hydrogen, silver chloride electrode and calomel electrode)
Indicator electrodes (metal electrodes and glass electrode)
Methods to determine end point of potentiometric titration
and applications
Potentiometry is the method to find the concentration of solute in
A given solution by measuring the potential between two Electrodes
(reference and Indicator electrode) . Potentiometric titration involves
the measurement of the potential of the indicator electrode and
reference electrode.
In potentiometric titration reference and indicator electrodes are
immersed in the solution of particular analyte (titrand) and
potential of indicator electrode is measured with relation to
reference electrode.
Titrant is added in analyte (Titrand) and change in potential is noted
down.
At the end point there is sharp change in potential on indicator
electrode.
Graph is plotted between the indicator electrode potential and
volume of titrant added.
This method is used for determination of sharp end point.
Types of Potentiometric Titration
1. Acid-base titration 2. Redox Titration 3.Complexometric titration 4. Precipitation Titration
Introduction to Pharmaceutical ChemistryPriti Kokate
Chapter No. 1 from pharmaceutical chemistry , updated syllabus notes as per MSBTE
1.Introduction to pharmaceutical chemistry
Topic covers following bits
#Scope
#Objective
#Sources & Types Of Errors
#Impurities in Pharmaceuticals
#Limit Test For
*Chloride
*Sulphate
*Iron
*Heavy Metal
*Arsenic
Impurities in pharmaceutical substancesShaliniBarad
Impurities definition
Sources of impurities
Effect/ type of impurities
Limit test definition
Limit test Importance,
Principle & procedure of Limit test for iron, chloride, sulphate, arsenic & heavy metals.
Pharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptx
Isotopes Types of decay
Alpha rays, which could barely penetrate a piece of paper
Beta rays, which could penetrate 3 mm of aluminium
Gamma rays, which could penetrate several centimetres of lead
Units of Radioactivity:
Measurement of Radioactivity
The measurement of nuclear radiation and detection is an important aspect in the identification of type of radiations (, , ) and to assay the radionuclide emitting the radiation, suitable detectors are required. The radiations are identified on the basis of their properties.
e.g. Ionization effect is measured in Ionization Chamber, Proportional Counter and Geiger Muller Counter.
The scintillation effect of radiation is measured using scintillation detector and the photographic effect is measured by Autoradiography.
Gas Filled Detectors:
Ionization Chamber:
Proportional Counters:
Geiger-Muller Counter
Properties of α, β, γ radiations
Half –life of Radioelement
Sodium Iodide (I131)
Handling and Storage of Radioactive Material:
Storage of Radioactive Substances –
Precautions For Handling Radioactive Substances
Labelling of Radioactive Substances
Pharmaceutical Application Of Radioactive Substances
Quality control drugs and pharmaceuticalsSHIVANEE VYAS
The term quality control is the most important in pharmaceutical industries. It is essential that a good quality product should be available to the doctors for treating patient or for the actual users. The term quality is applied to drugs and drug products which contributing directly or indirectly to the purity, safety & effectiveness of the products.
Define Impurities, 3 Types of Impurities, 13 Sources of Impurities - Raw martials, Reagents used, Methods used, Chemical process, Solvent, Atmospheric contamination, Intermediate process, Defect in manufacturing process, Manufacturing hazards, Impurities due to Storage condition, Impurities due to Crystal packing, Decomposition of product, Adulteration.
Types and Sources of impurities.pptx Pharmaceutical Inorganic chemistry UNIT-...Ms. Pooja Bhandare
Types and Sources of impurities. Pharmaceutical Inorganic chemistry UNIT-I (Part-II) Impurities:
Impure Chemical Compound
Pure Chemical Compound.
Types of impurities: Organic Impurity, Inorganic impurity, Residual solvent, Sources of Impurities in Pharmaceuticals
The different sources of impurities in pharmaceuticals are listed below:
Raw material used in manufacture
Reagents used in manufacturing process
Method/ process used in manufacture or method of manufacturing
Chemical processes used in the manufacture
Atmospheric contamination during the manufacturing process
Intermediate products in the manufacturing process
Defects in the manufacturing process
Manufacturing hazards
Inadequate Storage conditions
Decomposition of the product during storage
Accidental substitution or deliberate adulteration with spurious or useless materials.
Test for purity: Pharmacopoeia prescribes the “Test for purity” for pharmaceutical substances to check their freedom from undesirable impurities.
Pharmacopoeia will decide and fix the limit of tolerance for these impurities.
For certain common impurities for which pharmacopoeia prescribes the test of purity are:
Colour, odour, taste
Physicochemical constants (Iodine value, saponification value, melting point, refractive index etc.)
Acidity, alkalinity, pH
Humidity (Estimation of moisture)
Cations and anions
Insoluble Constituent or Residue.
Ash, Water insoluble ash
Arsenic or lead
Loss on drying
Loss on ignition.
Effect of Impurities
Sources of impurities, raw materials as a source of impurity, manufacturing methods as a source of impurity, reagents, solvents and reaction vessels as a source of impurity, manufacturing hazards as a source of impurity, physical and chemical stability of pharmaceuticals during storage, the reaction of pharmaceuticals with containers or storage vessels, thermal decomposition of pharmaceuticals, the use of water in the pharmaceutical industry, atmospheric contamination as a source of impurity, intermediate compounds as a source of impurity, cross-contamination of pharmaceutical powders, contamination of drugs by microbes, contamination of pharmaceuticals by particulate matter, errors in the manufacturing process as a source of impurity, storage of pharmaceuticals in amber-colored bottles, storage of drugs in a cool temperature, rubber closures as a source of impurity, natural sources of drugs, animal sources of drugs, plant sources of drugs, microorganism as a source of drugs, minerals as a source of drugs, effect of arsenic in human body, effect of excess of chlorine, iron and sulphate in human body, types of impurity.
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Environmental Catalysis Module: Students examines different types of catalytic systems, including heterogeneous and homogeneous catalysis. Depending on the knowledge they gained during activities, the students are then asked to design their projects.
Our Project:
"Eliminating Amyl acetate From Effluent"
Our aim is to treat wastewater produced from food-manufacturing company to prevent effluent from becoming an environmental nuisance .
Seminar of U.V. Spectroscopy by SAMIR PANDASAMIR PANDA
Spectroscopy is a branch of science dealing the study of interaction of electromagnetic radiation with matter.
Ultraviolet-visible spectroscopy refers to absorption spectroscopy or reflect spectroscopy in the UV-VIS spectral region.
Ultraviolet-visible spectroscopy is an analytical method that can measure the amount of light received by the analyte.
Earliest Galaxies in the JADES Origins Field: Luminosity Function and Cosmic ...Sérgio Sacani
We characterize the earliest galaxy population in the JADES Origins Field (JOF), the deepest
imaging field observed with JWST. We make use of the ancillary Hubble optical images (5 filters
spanning 0.4−0.9µm) and novel JWST images with 14 filters spanning 0.8−5µm, including 7 mediumband filters, and reaching total exposure times of up to 46 hours per filter. We combine all our data
at > 2.3µm to construct an ultradeep image, reaching as deep as ≈ 31.4 AB mag in the stack and
30.3-31.0 AB mag (5σ, r = 0.1” circular aperture) in individual filters. We measure photometric
redshifts and use robust selection criteria to identify a sample of eight galaxy candidates at redshifts
z = 11.5 − 15. These objects show compact half-light radii of R1/2 ∼ 50 − 200pc, stellar masses of
M⋆ ∼ 107−108M⊙, and star-formation rates of SFR ∼ 0.1−1 M⊙ yr−1
. Our search finds no candidates
at 15 < z < 20, placing upper limits at these redshifts. We develop a forward modeling approach to
infer the properties of the evolving luminosity function without binning in redshift or luminosity that
marginalizes over the photometric redshift uncertainty of our candidate galaxies and incorporates the
impact of non-detections. We find a z = 12 luminosity function in good agreement with prior results,
and that the luminosity function normalization and UV luminosity density decline by a factor of ∼ 2.5
from z = 12 to z = 14. We discuss the possible implications of our results in the context of theoretical
models for evolution of the dark matter halo mass function.
Slide 1: Title Slide
Extrachromosomal Inheritance
Slide 2: Introduction to Extrachromosomal Inheritance
Definition: Extrachromosomal inheritance refers to the transmission of genetic material that is not found within the nucleus.
Key Components: Involves genes located in mitochondria, chloroplasts, and plasmids.
Slide 3: Mitochondrial Inheritance
Mitochondria: Organelles responsible for energy production.
Mitochondrial DNA (mtDNA): Circular DNA molecule found in mitochondria.
Inheritance Pattern: Maternally inherited, meaning it is passed from mothers to all their offspring.
Diseases: Examples include Leber’s hereditary optic neuropathy (LHON) and mitochondrial myopathy.
Slide 4: Chloroplast Inheritance
Chloroplasts: Organelles responsible for photosynthesis in plants.
Chloroplast DNA (cpDNA): Circular DNA molecule found in chloroplasts.
Inheritance Pattern: Often maternally inherited in most plants, but can vary in some species.
Examples: Variegation in plants, where leaf color patterns are determined by chloroplast DNA.
Slide 5: Plasmid Inheritance
Plasmids: Small, circular DNA molecules found in bacteria and some eukaryotes.
Features: Can carry antibiotic resistance genes and can be transferred between cells through processes like conjugation.
Significance: Important in biotechnology for gene cloning and genetic engineering.
Slide 6: Mechanisms of Extrachromosomal Inheritance
Non-Mendelian Patterns: Do not follow Mendel’s laws of inheritance.
Cytoplasmic Segregation: During cell division, organelles like mitochondria and chloroplasts are randomly distributed to daughter cells.
Heteroplasmy: Presence of more than one type of organellar genome within a cell, leading to variation in expression.
Slide 7: Examples of Extrachromosomal Inheritance
Four O’clock Plant (Mirabilis jalapa): Shows variegated leaves due to different cpDNA in leaf cells.
Petite Mutants in Yeast: Result from mutations in mitochondrial DNA affecting respiration.
Slide 8: Importance of Extrachromosomal Inheritance
Evolution: Provides insight into the evolution of eukaryotic cells.
Medicine: Understanding mitochondrial inheritance helps in diagnosing and treating mitochondrial diseases.
Agriculture: Chloroplast inheritance can be used in plant breeding and genetic modification.
Slide 9: Recent Research and Advances
Gene Editing: Techniques like CRISPR-Cas9 are being used to edit mitochondrial and chloroplast DNA.
Therapies: Development of mitochondrial replacement therapy (MRT) for preventing mitochondrial diseases.
Slide 10: Conclusion
Summary: Extrachromosomal inheritance involves the transmission of genetic material outside the nucleus and plays a crucial role in genetics, medicine, and biotechnology.
Future Directions: Continued research and technological advancements hold promise for new treatments and applications.
Slide 11: Questions and Discussion
Invite Audience: Open the floor for any questions or further discussion on the topic.
Comparing Evolved Extractive Text Summary Scores of Bidirectional Encoder Rep...University of Maribor
Slides from:
11th International Conference on Electrical, Electronics and Computer Engineering (IcETRAN), Niš, 3-6 June 2024
Track: Artificial Intelligence
https://www.etran.rs/2024/en/home-english/
(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
In this webinar we give an overview of advanced applications of the IVM system in preclinical research. IVIM technology is a provider of all-in-one intravital microscopy systems and solutions optimized for in vivo imaging of live animal models at sub-micron resolution. The system’s unique features and user-friendly software enables researchers to probe fast dynamic biological processes such as immune cell tracking, cell-cell interaction as well as vascularization and tumor metastasis with exceptional detail. This webinar will also give an overview of IVM being utilized in drug development, offering a view into the intricate interaction between drugs/nanoparticles and tissues in vivo and allows for the evaluation of therapeutic intervention in a variety of tissues and organs. This interdisciplinary collaboration continues to drive the advancements of novel therapeutic strategies.
Deep Behavioral Phenotyping in Systems Neuroscience for Functional Atlasing a...Ana Luísa Pinho
Functional Magnetic Resonance Imaging (fMRI) provides means to characterize brain activations in response to behavior. However, cognitive neuroscience has been limited to group-level effects referring to the performance of specific tasks. To obtain the functional profile of elementary cognitive mechanisms, the combination of brain responses to many tasks is required. Yet, to date, both structural atlases and parcellation-based activations do not fully account for cognitive function and still present several limitations. Further, they do not adapt overall to individual characteristics. In this talk, I will give an account of deep-behavioral phenotyping strategies, namely data-driven methods in large task-fMRI datasets, to optimize functional brain-data collection and improve inference of effects-of-interest related to mental processes. Key to this approach is the employment of fast multi-functional paradigms rich on features that can be well parametrized and, consequently, facilitate the creation of psycho-physiological constructs to be modelled with imaging data. Particular emphasis will be given to music stimuli when studying high-order cognitive mechanisms, due to their ecological nature and quality to enable complex behavior compounded by discrete entities. I will also discuss how deep-behavioral phenotyping and individualized models applied to neuroimaging data can better account for the subject-specific organization of domain-general cognitive systems in the human brain. Finally, the accumulation of functional brain signatures brings the possibility to clarify relationships among tasks and create a univocal link between brain systems and mental functions through: (1) the development of ontologies proposing an organization of cognitive processes; and (2) brain-network taxonomies describing functional specialization. To this end, tools to improve commensurability in cognitive science are necessary, such as public repositories, ontology-based platforms and automated meta-analysis tools. I will thus discuss some brain-atlasing resources currently under development, and their applicability in cognitive as well as clinical neuroscience.
What is greenhouse gasses and how many gasses are there to affect the Earth.moosaasad1975
What are greenhouse gasses how they affect the earth and its environment what is the future of the environment and earth how the weather and the climate effects.
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
Cancer cell metabolism: special Reference to Lactate PathwayAADYARAJPANDEY1
Normal Cell Metabolism:
Cellular respiration describes the series of steps that cells use to break down sugar and other chemicals to get the energy we need to function.
Energy is stored in the bonds of glucose and when glucose is broken down, much of that energy is released.
Cell utilize energy in the form of ATP.
The first step of respiration is called glycolysis. In a series of steps, glycolysis breaks glucose into two smaller molecules - a chemical called pyruvate. A small amount of ATP is formed during this process.
Most healthy cells continue the breakdown in a second process, called the Kreb's cycle. The Kreb's cycle allows cells to “burn” the pyruvates made in glycolysis to get more ATP.
The last step in the breakdown of glucose is called oxidative phosphorylation (Ox-Phos).
It takes place in specialized cell structures called mitochondria. This process produces a large amount of ATP. Importantly, cells need oxygen to complete oxidative phosphorylation.
If a cell completes only glycolysis, only 2 molecules of ATP are made per glucose. However, if the cell completes the entire respiration process (glycolysis - Kreb's - oxidative phosphorylation), about 36 molecules of ATP are created, giving it much more energy to use.
IN CANCER CELL:
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
introduction to WARBERG PHENOMENA:
WARBURG EFFECT Usually, cancer cells are highly glycolytic (glucose addiction) and take up more glucose than do normal cells from outside.
Otto Heinrich Warburg (; 8 October 1883 – 1 August 1970) In 1931 was awarded the Nobel Prize in Physiology for his "discovery of the nature and mode of action of the respiratory enzyme.
WARNBURG EFFECT : cancer cells under aerobic (well-oxygenated) conditions to metabolize glucose to lactate (aerobic glycolysis) is known as the Warburg effect. Warburg made the observation that tumor slices consume glucose and secrete lactate at a higher rate than normal tissues.
Observation of Io’s Resurfacing via Plume Deposition Using Ground-based Adapt...Sérgio Sacani
Since volcanic activity was first discovered on Io from Voyager images in 1979, changes
on Io’s surface have been monitored from both spacecraft and ground-based telescopes.
Here, we present the highest spatial resolution images of Io ever obtained from a groundbased telescope. These images, acquired by the SHARK-VIS instrument on the Large
Binocular Telescope, show evidence of a major resurfacing event on Io’s trailing hemisphere. When compared to the most recent spacecraft images, the SHARK-VIS images
show that a plume deposit from a powerful eruption at Pillan Patera has covered part
of the long-lived Pele plume deposit. Although this type of resurfacing event may be common on Io, few have been detected due to the rarity of spacecraft visits and the previously low spatial resolution available from Earth-based telescopes. The SHARK-VIS instrument ushers in a new era of high resolution imaging of Io’s surface using adaptive
optics at visible wavelengths.
Observation of Io’s Resurfacing via Plume Deposition Using Ground-based Adapt...
Impurities
1. 1
Punatipharma
Sree Dattha Institute of Pharmacy LingeswaraRao.Punati
Ph.D
Impurities
Impurities defined as a foreign particle that affects the purity of a substance.
Usually, impurities occurring in many pharmaceutical or medicinal preparations
may be of the following types.
1. Foreign particle that bring about adverse or toxic reactions when present in
excess beyond their limits.
Example: lead, heavy metals, arsenic etc.
2. Impurities which may not cause toxic effects but bring about deterioration of
the activity of chemical.
Example: hard soap containing excess of water.
3. Impurities that cause incompatibility of active ingredient with other
substanceor which reduce the properties of active ingredient.
4. Impurities which may lead to technical problems in the applications of the
substance.
Example: presence of carbonate in ammonia solution, presence of KIO3 in KI
solution.
5. Impurities arising due to humidity temperature.
Example: presence of very low amount of moisture may enable substance to get
oxidized easily or may reduce its free flowing characteristics.
6. Impurities arising due to colouring and flavoring substances. These
impurities can be detected by changes in colour, odour, taste and
appearance.
2. 2
Punatipharma
Sree Dattha Institute of Pharmacy LingeswaraRao.Punati
Ph.D
Examples: Presences of phenolic compounds decolourize sodium salicylate,
presence of minute quantities of magnesium salt causes dampening of sodium
chloride.
7. Impurities which may alter the physical and chemical properties of the
substance.
8. Impurities which decrease the shelf – life.
Source of impurities
Raw materials conditions of storage packing errors
Method / process atmospheric deliberate adulteration
Starting material or Reagents careless storage
Reagents employed to eliminate other impurities filthy matter
Solvents or vehicles used in the manufacturing effect of container materials
Equipment used in the process ofmanufacturing
Intermediates generated during the synthesis
Chemical method used in the manufacturing process
Defects in the process ofmanufacturing
Manufacturing hazards
3. 3
Punatipharma
Sree Dattha Institute of Pharmacy LingeswaraRao.Punati
Ph.D
Raw materials:
Generally, most of the raw materials used in the manufacturing of pharmaceutical
products are naturally occurring substances. Traces of the elements present in the
raw materials may get carried to the final preparation.
Pharmaceuticalpreparation Raw materials Impurities present
Sodium compounds Sodium chloride rock
salt
Chlorides, Ca and Mg
Bismuth compounds Bismuth salts Lead, copper, and silver
Coppercompounds Copperturnings Arsenic and iron
Zinc compound Zinc metal or zinc
oxide
Aluminum, copper,
manganese,Mg, arsenic,
iron and nickel.
Therefore, proper measures should be taken to ensure the purity of raw materials
used in the manufacture.
Method / process of manufacture:
Manufacturing process involves various reactions carried out in single or multiple
steps. Starting from the raw materials used, equipment, reactions, intermediates
produced, solvents employed to the status of completion of the reaction, every
aspectserves as the source of impurity. These are explained as follows.
Starting materials or reagents used:
Many reagents are used in the process of manufacturing a product. If the products
are not washed properly to remove excess reagents, then these reagents are liable
to be carried as impurities to the final preparation.
4. 4
Punatipharma
Sree Dattha Institute of Pharmacy LingeswaraRao.Punati
Ph.D
Examples:
Calcium carbonate is prepared from the reagents calcium chloride and sodium
carbonate. Hence, calcium carbonate by this process is associated with alkali
(Na2CO3) and soluble chlorides. If the CaCO3 product is not washed properly to
remove excess of Na2CO3and chlorides, then they get carried as impurities. Due to
this reason, pharmacopeia has prescribed limits for soluble chlorides and alkali for
CaCO3.
CaCl2 + Na2CO3 CaCO3 + 2NaCl
In the synthesis of ammoniated mercury, dilute ammonia solution and mercuric
chloride solution are used as reagents. Proper washing of the end product
(ammoniated mercury) with cold water renders it completely free from impurities
(ammonium hydroxide).
HgCl2 + 2NH4OH NH2HgCl + NH4Cl + 2H2O
Reagentsemployed to eliminate other impurities:
In some manufacture process certain reagents are used to remove impurities
present in the final product, these reagents if not carefully used are liable to get
carried to the end product.
Example:
Barium is employed to remove excess sulphate in the synthesis of potassium
bromide. Improper usage results in the presence of very small amounts of barium
in the final product.
5. 5
Punatipharma
Sree Dattha Institute of Pharmacy LingeswaraRao.Punati
Ph.D
Solvents or vehicles used in the manufacturing
Water is the most commonly used solvent in many preparations. However, water
serves as a sourcefor many impurities.
Type of water Impurities present
Tap water Calcium, magnesium, sulphates, chlorides, sodium and
carbonates
Softened water Sodium and chloride
Demineralized water Organic impurities
Distilled water No impurities
Tap water is the cheapest solvent available but it contains many impurities.
Therefore, washing the final product with tap water leaves it with traces of
impurities and sometimes even adding additional impurities. Softened water is
prepared by passing tap water through sodium form of zeolite, such that sodium
ions from zeolite are exchanged for calcium and magnesium. However, sodium
and chlorine may get incorporated into the final preparation.
Demineralized water is prepared by passing tap water through the coloumn of ion –
exchange resins. All the impurities present in tap water except organic impurities
get eliminated. Therefore, in those preparations where demineralized water has
been used, the final productis liable to contain organic impurities.
Distilled water is free from both organic as well inorganic impurities but it is very
expensive. Hence, its use is limited.
6. 6
Punatipharma
Sree Dattha Institute of Pharmacy LingeswaraRao.Punati
Ph.D
Equipmentused in the process of manufacturing
Equipments or reactions vessels employed in the manufacturing process are made
of glass, tuber, metals or their alloys. The material of the equipment may react with
the reagents and solvents used in the process of manufacturing and contribute to
impurities in the end product.
Material of the equipment Impurity
Iron Arsenic
Galvanized iron Zinc
Sodaglass Alkali
Stream or waste pipe lead
In order to control the impurities arising from chemical reactions between the
solvents, reagents or both with the reaction vessel, vessel made from hard inert
glass like pyrex – borosilicate glass should be used. However, its high cost limits
its use.
Intermediatesgenerated during the synthesis
Most of the preparations involve generation of intermediates. If these intermediate
products are not completely converted into the final product, they get incorporated
as impurities.
Example:
In the preparation of potassium iodide ( KI) from potassium hydroxide and iodine,
potassium iodate (KIO3) is formed as an intermediate. KIO3 is evaporated to
dryness and the residue obtained is heated with charcoal to get KI. Incomplete or
7. 7
Punatipharma
Sree Dattha Institute of Pharmacy LingeswaraRao.Punati
Ph.D
improper conversion of KIO3 is liable to be carried as an impurity to the final
preparation which is desirable.
6KOH + 3I2 5KI + KIO3 +3H2O
KIO3 + 3C KI + 3CO
Chemicalmethods used in the manufacturing process:
A substance or a reagent is subjected to a variety of chemical reactions during the
manufacturing process. The type of chemical reactions like halogenations,
oxidation, reduction, nitration, hydrolysis etc., employed may also contribute to the
presence of impurities in the final preparation.
Example:
Potassium iodide is synthesized from kelp (ash of a sea weed). When sea weed
containing nitrogenous organic matter is heated at very high temperature in the
presence of alkli, cyanides are generated. These cyanides may get incorporated as
an impurity.
Defects in the process of manufacturing
Synthesis of a compound should be carried out under appropriate conditions along
with correct measures of preparation. Improper mixing, incompleteness of the
reaction, inappropriate temperature, preasure and pH conditions yield compounds
with impurities.
8. 8
Punatipharma
Sree Dattha Institute of Pharmacy LingeswaraRao.Punati
Ph.D
Examples:
Synthesis of calcium chloride involves addition of pure calcium carbonate to
slightly excess quantity of dilute hydrochloric acid with continuous stirring
followed by filtration and concentration of filtrate to give CaCl2 crystals.
If the ingredients are not mixed properly or if any amount of HCl passes through
the filter or if the concentration is not properly carried out, then it affects the final
product.
CaCO3 + 2HCl CaCl2 + H2O + CO2
Manufacturinghazards:
Hazardous and toxic substance such as dust, paints, fuel or chemicals present in the
work place are capable of causing harm to the pharmaceutical products. The
manufacturer should provide analytical procedure to limit such impurities. The
manufacturing errors may go unnoticed. These are typical errors that occur due to
microbial contamination, particulate contamination etc. specifications and
analytical procedures are employed to estimate the identified or unidentified
impurities and also to include limits for impurities.
i. Arbitrary inclusion of particulatematter:
The hazardous substance such as dirt, glass, metallic ions, porcelain, plastic
fragments found during the operations like granulating, tabletting or in equipment
like sieves, filling machines, product container etc., may be accidentally introduced
into the pharmaceutical products.
Example:
9. 9
Punatipharma
Sree Dattha Institute of Pharmacy LingeswaraRao.Punati
Ph.D
Eye ointments packed in metal tubes made up of tin, aluminum generally get
contaminated due to the extrusion of metal particles from the packing material. The
extent of contamination depends upon the viscosity of the ointment. As the
viscosity of the ointment increases, the extent of extrusion increases.
ii. Arbitrary inclusion of microorganisms:
Almost all the pharmaceutical preparations may undergo microbial contamination
during the process of manufacture or during storage. Generally raw materials
obtained naturally are more prone to microbial contamination. Therefore to control
it, sterility tests should be performed on all the products, mainly upon liquids or
creams applied on the mucous membranes or broken skin, opthalamic and
parenteral preparations.
Materials Free from
Acacia, senna, and tragacanth Salmonella
Gelatin, pancreatin, starch, cochineal Salmonella and E.coli
Al(OH)3 gel, dried Al(OH)3 gel and
aluminum phosphate gel
pseudomonas
iii. Cross contamination:
When large quantities of powders, granules and tablets are handled, a substantiate
amount of air borne dust generates. If it is not properly controlled, it leads to cross
contamination of the products.
Precautions
The use of face masks or special equipment help to curb impurities occurring by
cross contamination.
10. 10
Punatipharma
Sree Dattha Institute of Pharmacy LingeswaraRao.Punati
Ph.D
Conditions of storage:
Storage conditions determine the efficacy and stability of the product. Requirement
of storage differ from one drug to the other. Various factors like material of the
container temperature, reactions taking place in the product., affect the final
preparation during the storage.
a) Carless storage:
Pharmaceutical preparations behavior when not stored properly.
Example:
Ferrous sulphate should be stored in air tight containers. Improper storage leads to
the conversion of soluble ferrous sulphate to insoluble ferric oxide in the presence
of air and moisture.
b) Filthy matter:
Dust particles, microorganisms, insect excreta etc., may affect the final
preparations. Novel packing techniques available inhibit contamination of the end
product, but raw materials are more likely to be attacked by filth during storage.
c) Effect of container materials
Pharmaceutical preparations when stored in inappropriate containers react with the
material of the containers undergo deterioration.
Examples:
Salicylic acid reacts with metal tubes, therefore, it should not be stored in metal
tubes unless and until they are lacquered internally.
11. 11
Punatipharma
Sree Dattha Institute of Pharmacy LingeswaraRao.Punati
Ph.D
Atropine sulphate injection should be strictly packed in glass ampoules as it offers
hydrolytic resistance.
Therefore, a container should be so selected such that it is suitable for storing the
preparation and does not contribute to its degradation.
There are grades of glass containers available.
Type I: it exhibits very high hydrolytic resistance. It is a neutral glass.
Type II: it is formed by the surface treatment of glass and exhibit very high
hydrolytic resistance.
Type I and II glasses can be differentiated from each other by crushed glass test.
Type III: it possessesvery limited hydrolytic resistance.
Aqueous solutions of injections should be stored in either type I or II glass
containers while non – aqueous solutions as well as injectable solids are stored in
type III glass containers after complying with the test for hydrolytic resistance.
4. Atmospheric / environmental conditions:
Atmospheric conditions during manufacturing process as well as during storage
affect the quality of the final preparation.
Example: if sodium hydroxide is exposed to air for very long periods during the
process of manufacturing it reacts with carbon dioxide and gets converted to
sodium carbonate. This sodium carbonate gets incorporated into NaOH and serves
as an impurity.
2NaOH + CO2 Na2CO3 + H2O
12. 12
Punatipharma
Sree Dattha Institute of Pharmacy LingeswaraRao.Punati
Ph.D
5. Packing Errors:
Crystal packing of solids may lead to serve reactions which may affect the
preparation. Pharmaceutical products having same physical appearance i.e., size,
shape, colour, if packed in same type of containers may lead to packaging errors.
This leads to mislabeling of the products. Therefore handling similar type of
products at the same time should be avoided.
6. Deliberate adulteration or international substitution
Substitution of a pure product spurious, cheap, inferior, defective or toxic
substance is termed as adulteration. Accidental adulteration can be prevented by
storing away from harmful substances separately from purified substances.